This is a chronological listing of grants held by this department, with the most recent listed first. New grants appear in this list weekly and contribute related to the department's Research Profile. The source of grants for this application comes directly from your institution.
SHH4476G A Pivotal Phase II, Multicenter, Single-Arm, Two-Cohort Trial Evalua
Stephen Bernard9/23/2009 - 9/22/2012
|Sponsoring Organization:||Industry Sponsor|
|Awarding Organization Is:||University of North Carolina at Chapel Hill|
Stephen A Bernard (Lead Principal Investigator)
Primary Objective The primary objective of this study is to estimate the clinical benefit of GDC-0449 given as therapy for patients with locally advanced or metastatic basal cell carcinoma (BCC), as measured by overall response rate (ORR). Secondary Objectives The secondary objectives of this study are the following: • To estimate the duration of response, progression-free survival (PFS), and overall survival (OS) • To assess the safety and tolerability of GDC-0449 in this patient population • To assess the pharmacokinetics of GDC-0449 in this population (at participating sites only) • To assess patient-reported outcomes • To assess the histopathologic effect of GDC-0449 in tumor biopsies obtained at baseline and following GDC-0449 treatment in patients with locally advanced BCC • To evaluate the status of the Hh signaling pathway using quantitative reverse transcriptase polymerase chain reaction (qRT-PCR) in archival tissue